- Electronic Records; Electronic Signatures (21 CFR Part 11)
- Human Subject Protection (Informed Consent) (21 CFR Part 50)
- Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (Interim Rule) (21 CFR Part 50, subpart D)
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)
- Institutional Review Boards (21 CFR Part 56)
- Investigational New Drug Application (21 CFR Part 312)
- Forms 1571 (Investigational New Drug Application) and 1572 (Statement of Investigator)
- Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
- Applications for FDA Approval of a Biologic License (21 CFR Part 601)
- Investigational Device Exemptions (21 CFR Part 812)
- Premarket Approval of Medical Devices (21 CFR Part 814